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Category: Innovation


Innovation, Med Tech

Healthcare app regulators are adapting to increased activity

February 8, 2024

Via: Medical Device Network

Two very distinct types of apps focus on healthcare: the nebulous wellness category and regulated digital therapeutics. This divide is due to national regulatory bodies such as the US Food and Drug Administration (FDA) that oversee the approval of apps […]


Innovation, Patient Experience

Five ways disconnected consent is impacting patient experiences

February 7, 2024

Via: Medical Device Network

One critical aspect of patient-provider interactions that often goes overlooked is consent. When consent management processes are disconnected or poorly managed, it can have a detrimental impact on patient experiences. With many healthcare providers managing multiple tech stacks across siloed […]


Innovation, Med Tech

2024: The Year of Smarter Automation and AI in Healthcare Revenue Cycle

February 6, 2024

Via: HitConsultant

Some may be fatigued by it, or even afraid of it, but the reality is AI is here to stay in 2024. The best thing we can all do is learn how to leverage it to make our jobs easier. […]


Innovation, Medical Devices

More guidance needed to use RWE to support device approvals in EU

February 5, 2024

Via: Medical Device Network

There is little to no guidance by the European Medicines Agency (EMA) regarding the advanced use of RWE such as external controls and virtual trials, said Dr Andreas Beust, CEO of German contract research organisation (CRO) GCP-Service International. The use […]


Innovation, Medical Devices

High risk devices can be exempted from mandatory trials under EU MDR

February 5, 2024

Via: Medical Device Network

Aclinical investigation may not be mandatory for Implantable and Class III medical devices under Article 61(4)-(6) of the European Union Medical Device Regulation (EU MDR) if one of four cases apply to the device under evaluation, said John Thomas, director […]


Biomarker, Innovation

FDA grants clearance for Hologic’s cervical cancer screening system

February 2, 2024

Via: Medical Device Network

The US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for cervical cancer screening. This system is claimed to be the first FDA-cleared digital cytology platform that […]


Innovation, Research

Alzheimer’s disease found to be transmitted through medical procedures decades ago, study finds

February 1, 2024

Via: Fox News

Alzheimer’s disease has been considered something that happens from within, generally speaking — but for the first time, researchers have identified cases that were triggered by a specific medical treatment. The most common type of dementia, Alzheimer’s is caused by […]


Innovation, Med Tech

FDA extends deadline for comments on role of digital health in diabetes detection

February 1, 2024

Via: Healthcare Dive

The FDA believes the healthcare sector is yet to realize the full potential of DHTs in the detection of diabetes, “especially in diverse populations, particularly racial and ethnic minorities.” The agency sees the technologies as an enabler of the focus […]


Innovation, Research

PathAI Expands PathExplore Reach to 14 Cancer Types, Fueling Precision Oncology

January 31, 2024

Via: HitConsultant

Despite advances in cancer treatment, many patients remain unresponsive to available therapies or lack access to potentially life-saving options due to the absence of actionable biomarkers. The TME, a complex ecosystem of cells and tissues surrounding the tumor, holds immense […]


Innovation, Research

Kids who consume energy drinks are more prone to mental health disorders, study finds

January 31, 2024

Via: Fox News

Energy drinks could pose a risk to young brains, according to new research. Those who consumed energy drinks — which are intended to boost energy through the use of caffeine or other stimulants — were shown to have a higher […]


Innovation, Med Tech

Swift Medical Secures $8M to Power AI-Driven Wound Care

January 30, 2024

Via: HitConsultant

Swift Medical boasts a proven track record, serving as the trusted wound care partner for over 4,000 healthcare facilities across North America. Their platform empowers over 20,000 clinical users to deliver standardized, accessible, and equitable care to patients through: Advanced, […]


Biomarker, Innovation

US researchers initiate study to improve pancreatic cancer detection

January 30, 2024

Via: Medical Device Network

Researchers at OU Health Stephenson Cancer Center in Oklahoma, US, are initiating a study that could transform pancreatic cancer detection using MSOT imaging. This new imaging technique, combined with a specially designed contrast agent, has the potential to identify cancer […]


Innovation, Patient Experience

Unlocking Patient Insights with Conversational AI in Healthcare

January 25, 2024

Via: HitConsultant

Healthcare leaders should champion human-AI collaboration by having people work with AI to validate insights and develop engagement strategies. Organizations can — and should — implement conversational AI because it allows leaders to identify actionable areas of change and protects […]


Innovation, Med Tech

Siemens’ remote scanning software receives US FDA clearance

January 24, 2024

Via: Medical Device Network

Siemens Healthineers has received US Food and Drug Administration (FDA) approval for syngo Virtual Cockpit, a software that facilitates real-time remote scanning and collaboration among healthcare professionals. The multi-vendor scanning software allows radiologic technologists to connect with various scanners including […]


Biomarker, Innovation

Cognito starts biomarker substudy in Alzheimer’s device trial

January 23, 2024

Via: Medical Device Network

Cognito Therapeutics has enrolled the first patient in a biomarker substudy within its HOPE pivotal trial evaluating sensory stimulation device in Alzheimer’s disease patients. The HOPE study (NCT05637801) is assessing the efficacy of Cognitio’s GammaSense Stimulation system in subjects with […]


Biomarker, Innovation

National Health Service launches new ‘blood matching’ genetic test

January 22, 2024

Via: Medical Device Network

The National Health Service (NHS) in the UK has introduced a ‘blood matching’ genetic test, marking a global first in personalised healthcare for patients with sickle cell disorder and thalassaemia. This new blood group genotyping test is expected to benefit […]


Innovation, Med Tech

AI-Powered Innovations: Redefining Breast Cancer Screenings and Mammograms

January 22, 2024

Via: Health IT Answers

Breast cancer screenings can save lives through earlier detection. Mammograms are among the most common tests, although MRI scans and ultrasounds are other possibilities. Numerous studies show artificial intelligence (AI) could improve outcomes in various ways. Such results enable health […]


Innovation, Medical Devices

Calcivis to introduce preventive dental technology in US

January 19, 2024

Via: Medical Device Network

Medical device company Calcivis is set to launch its new preventive bioluminescent dental imaging system in the US. The move comes after the company secured final-stage US Food and Drug Administration (FDA) pre-market approval (PMA) for its new ergonomic, wireless, […]


Innovation, Research

Rising health insurance premiums linked to wage stagnation, study finds

January 17, 2024

Via: Healthcare Dive

Health insurance offered through employers represents the single largest source of coverage in the U.S. But premiums often rise faster than inflation and wage growth, frustrating employers who are on the hook for a large portion of climbing costs and […]


Innovation, Research

The New Era of Clinical Trials: Adopting Electronic Informed Consent

January 17, 2024

Via: HitConsultant

The clinical trials landscape continues to evolve and with it, an exponential growth in the adoption of electronic informed consent (eConsent) solutions. These solutions deliver a myriad of benefits for trial sponsors, sites and patients. However, there is still some […]